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FDA setting up new guidelines to boost complex generic drug development
  • By Lee Han-soo
  • Published 2017.11.30 10:28
  • Updated 2017.11.30 10:28
  • comments 0

Scott Gottlieb, the commissioner of the U.S. Food and Drug Administration (FDA), announced Tuesday that the agency is preparing new guidelines to bring more complex generic drugs into the market.

A complex generic drug is a generic drug where it is especially hard to establish therapeutic equivalence.

Scott Gottlieb commissioner of the U.S. Food and Drug Administration

“Often, these are cases where the drug involves a complex formulation or complex active ingredient,” Gottlieb said. “In other cases, the drug acts locally on tissue, like an inhaled medicine that acts directly on the lung, or an eye drop that acts on the surface of the eye.”

Such complexity can prove as an obstacle for many of the biopharmaceutical companies developing a complex generic drug from going through the FDA’s abbreviated new drug application (ANDA) pathway.

The ANDA pathway, established in 1984, is an application for a U.S. generic drug approval for an existing licensed medication or approved drug. The pathway was put in place when drug components were mainly composed of simple small molecules and were easy to characterize and evaluate through bioequivalence studies.

The problem deepens when the complex drug goes through sophisticated devices, such as inhalers or auto-injectors.

“The original drug maker may still hold international patents on certain features of the device. In such a circumstance, the drug can be an old medicine, but the device can be hard to copy since new patents protect its key features,” Gottlieb said. “When a generic competitor alters the device to avoid such patents it can raise questions about whether the generic product will have the same clinical effect and safety profile as the original.”

To avoid patent disputes, while verifying the safety of the generic product, the FDA is currently taking steps to set up a new guideline. The new guideline is expected to subject the generic product to approval as long as the generic applicant can demonstrate with data that differences in the design of the generic product do not affect the clinical effect or safety profile between the generic and the original product.

The new guideline is the latest series of efforts by the FDA to allow more generic drugs into the market.

In June, the FDA published a list of approximately 200 drugs that have fallen off patent and has no generic competition. The agency expects biopharmaceutical companies to make generic alternatives to the medications posted on the list and increase competition and lower prices. The FDA also plans on updating the list every six months.

“No patient should be priced out of the medicines they need, and as an agency dedicated to promoting public health, we must do our part to help patients get access to the treatments they require,” Gottlieb said at the time. “Getting safe and effective generic products to market in an efficient way, being risk-based in our own work and making sure our rules aren’t used to create obstacles to new competition can all help make sure that patients have access to more lower-cost options.”


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